IN PARTNERSHIP


InTemp ‘touchless’ temperature monitoring for clinical trials


Onset’s range of storage and cold-chain monitoring solutions now includes InTemp, a Bluetooth-enabled end-to-end temperature monitoring system for the pharmaceutical supply chain.


component of the clinical trials process. Gone are the days when the only option to monitor a cold chain shipment was to simply use a USB data logger that could later be read out with a computer, significantly delaying the confirmation that a drug is safe. Today, clinical trial managers need to confirm the efficacy of their drugs at the point of distribution, near real time. The InTemp temperature monitoring solution


E


by Onset provides a touchless, cost-effective internet of things (IoT) solution that meets the demands of today’s clinical trials. InTemp data loggers use Bluetooth Low Energy (BLE) technology to communicate with mobile devices or gateways.


In combination with the InTempConnect cloud platform, clinical trial managers can control specific temperature monitoring configurations for a particular shipment, as well as permissions for individuals with access to the loggers. They can view complete trip data as soon as the InTemp device is downloaded at its destination. A significant benefit of having a Bluetooth data logger solution is that communication to mobile devices and gateways enables the logger to be configured even when sealed inside clinical trial packaging, and data can be downloaded from the logger without having to open the packaging at its destination. This is very different from traditional USB data loggers, which require significant manual handling, programming, and downloading throughout the process. The InTemp system


nsuring the temperature efficacy of clinical trial drugs at the time of release to the patient is an increasingly critical


provides further control to clinical trial managers, because the combination of the cloud platform and mobile applications lets them determine who can download and view the temperature data. At the heart of the InTemp solution is


the InTempConnect cloud platform. Using InTempConnect, account administrators can: create specific temperature configuration profiles for different shipments; incorporate specific trip data; manage user roles and permissions; and create reports for analysis and compliance purposes. InTemp mobile apps and InTemp gateways used in the field connect to the InTempConnect cloud platform so users can directly configure, start, and download the InTemp Bluetooth data loggers. The standard InTemp mobile app requires a permission-based login to connect the user to an InTempConnect cloud account. The alternative InTemp mobile app, called InTempVerify, is ideal for direct-to-patient (DtP) applications. The public, no-charge InTempVerify app can be downloaded from the iOS or Android store by the patient or loaded on to the patient’s clinical trial tablet provided by the clinical trial administrator. With the InTempVerify app on a mobile device, the patient simply opens the app and selects the logger to be downloaded, after which the downloaded data is automatically sent to the InTempConnect account administrator for assessment. The patient user has no permission and no ability to stop or reconfigure the logger. Likewise, nurses, courier drivers, or anyone


else involved in the process can download the InTempVerify app to their mobile devices and automatically send logger data back to the


Clinical Trial Supply Handbook | 59


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92